Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer

November 18, 2021 updated by: Antonio J Conde Moreno, Grupo de Investigación Clínica en Oncología Radioterapia

This study aims to probe the effect of SBRT as a treatment oligometastases of prostate cancer, regardless of basal treatment received, and I know the response, biochemical control, the progression-free survival as well as their impact on quality of life.

Primary Objective: Local and symptomatic oligometastases Control of prostate cancer treated by SBRT.

Secondary Objectives: Analyzing biochemical progression rates, progression-free survival, chemotherapy-free survival and overall survival. Analyze toxicities and quality of life of patients before and after treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Instituto Catalan de Oncologia
      • Bilbao, Spain
        • Hospital de Cruces
      • Castellón De La Plana, Spain
        • C.H.P. Castellón
      • Las Palmas De Gran Canaria, Spain
        • Hospital Dr. Negrín
      • Madrid, Spain
        • Hospital Ramón y Cajal
      • Madrid, Spain
        • Hospital Universitario de La Princesa
      • Madrid, Spain
        • Hospital Ruber Internacional
      • Madrid, Spain
        • Clinica Quiron
      • Madrid, Spain
        • Hospital Central de la Defensa Gómez Ulla
      • Madrid, Spain
        • Hospital de Sanchinarro
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • Navarro, Spain
        • Hospital de Navarra
      • Salamanca, Spain
        • Hospital Universitario Clinico de Salamanca
      • Santander, Spain
        • Hospital Marques de Valdecilla
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain
        • ERESA H. General de Valencia
      • Vigo, Spain
        • Hospital Do Mexoeiro
      • Zaragoza, Spain
        • Hospital Miguel Servet
    • Las Rozas
      • Madrid, Las Rozas, Spain, 28290
        • GICOR
    • Madrid
      • Majadahonda, Madrid, Spain
        • Hospital Puerta de Hierro
      • Móstoles, Madrid, Spain
        • Hospital Rey Juan Carlos
    • Murcia
      • Cartagena, Murcia, Spain
        • Santa Lucia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients with histologically confirmed prostate cancer, who are currently being oligometastases / oligorrecurrencia after primary treatment for their disease.
  • Aged ≥ 18 years
  • Time to biochemical recurrence more than 1 year
  • PSA doubling time> 3 months
  • Less than 5 bone metastases location (including spinal) or lymph node.
  • Without other metastases or recurrences by Choline PET or / and NMR Diffusion Length.
  • Signed and dated written informed consent form.

Exclusion Criteria:

  • Patients currently treatment with abiraterone, enzalutamide, chemotherapy, immunotherapy or radioisotopes.
  • Patients unwilling or unable to comply with protocol requirements and scheduled visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT
Stereotactic Body Radiation Therapy for Oligometastases (SBRT)
Radiation: Stereotactic Body Radiation Therapy for Oligometastases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients without disease progression of prostate cancer treated by SBRT
Time Frame: 5 years
Number of patients without disease progression of local and symptomatic oligometastases of prostate cancer treated by SBRT expressed as total number and percentage
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival measured with Kaplan-Meier method
Time Frame: patients will be followed up an average of 5 years
the time to death will be defined as the time between the date when the patient is treated with SBRT and the date of death, or the last follow-up visit.
patients will be followed up an average of 5 years
Number of patients with an adverse events.
Time Frame: 3 months after the SBRT treatment
Analyze toxicities in every patient during the first 3 months after the treatment with SBRT. Every significant Adverse Event will be graded as CTC-AE v.4.03. For Pain related adverse events, visual analogic scale (VAS) will be used.
3 months after the SBRT treatment
Free disease progression survival measured with Kaplan-Meier method
Time Frame: the patients will be followed up an expected average of 5 years
the time to disease progression will be defined as the time between the date when the patient is treated with SBRT and the date of biochemical (PSA increased upper to 2 ng/mL) o radiological progression or the last follow-up visit.
the patients will be followed up an expected average of 5 years
Quality of life questionnaire FACT-P
Time Frame: baseline and 3rd month after the SBRT treatment.
The Functional Assessment Of Cancer Therapy-Prostate Questionnaire (FACT-P) will be performed at baseline and 3 months after the SBRT treatment.
baseline and 3rd month after the SBRT treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Investigación Clínica en Oncología Radioterapia

Investigators

  • Principal Investigator: Antonio J Conde Moreno, MD, Grupo de Investigación Clínica en Oncología Radioterapia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

July 3, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBRT-SG 05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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